norethindrone

Generic: norethindrone

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone
Generic Name norethindrone
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-305
Product ID 68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091209
Listing Expiration 2027-12-31
Marketing Start 2010-11-03

Pharmacologic Class

Established (EPC)
progestin [epc]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462305
Hyphenated Format 68462-305

Supplemental Identifiers

RxCUI
198042 748961
UPC
0368462305843
UNII
T18F433X4S
NUI
M0447349 N0000175602

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name norethindrone (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA091209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH (68462-305-84)
source: ndc

Packages (1)

68462-305-29 3 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH (68462-305-84)

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Norethindrone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5a1f7007-bfeb-4899-a1a3-b3c005cbcabb", "openfda": {"nui": ["M0447349", "N0000175602"], "upc": ["0368462305843"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["0d2f8fea-3675-40d2-afd9-9fcb148dbd4b"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (68462-305-29)  / 28 TABLET in 1 POUCH (68462-305-84)", "package_ndc": "68462-305-29", "marketing_start_date": "20101103"}], "brand_name": "Norethindrone", "product_id": "68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabb", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68462-305", "generic_name": "Norethindrone", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA091209", "marketing_category": "ANDA", "marketing_start_date": "20101103", "listing_expiration_date": "20271231"}